July 20, 2020

The U.S. FDA has approved an expanded indication for Qutenza® (capsaicin 8%) patch, manufactured by Averitas Pharma. The drug is now indicated to treat neuropathic pain associated with diabetic peripheral neuropathy (DPN) in addition to its original indication for the treatment of neuropathic foot pain associated with postherpetic neuralgia (PHN).

Neuropathic foot pain associated with DPN is the result of nerve damage, one possible complication of diabetes. Symptoms of DPN can include numbness, tingling or burning sensations, sharp pains, cramping, extreme sensitivity to touch, ulcers, infections, and bone and joint pain.

In a clinical study, patients diagnosed with DPN-associated neuropathic foot pain received either Qutenza or a placebo. Individuals treated with Qutenza experienced a greater reduction in their average pain level than those given the placebo.

Recommended dosing for neuropathic pain of the feet associated with DPN is up to four patches used in a single, 30-minute application on the feet. Treatment can be repeated as often as every three months or as warranted by the return of pain. Qutenza should not be used more often than every three months. The product must be administered in a well-ventilated treatment area by a physician or another healthcare professional under the close supervision of a physician, and should never be dispensed to patients for self-administration.

Qutenza first received FDA approval in 2009.

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